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FDA Orders New Labeling on Finasteride
MedPageToday, 2012WASHINGTON -- Labeling for finasteride (Propecia/Proscar) will soon have an expanded list of potential sexual adverse events, the FDA has announced.
The labeling changes affect brand-name and generic finasteride formulations used for treatment of benign prostatic hyperplasia (5 mg) and for alopecia areata (1 mg).
Responding to event reports filed with the FDA, the agency will require manufacturers to add information about the following adverse events: Finasteride 1 mg -- Libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug Finasteride 5 mg -- Decreased libido that continued after discontinuation of the drug Finasteride 1 mg and 5 mg -- Male infertility and/or poor semen quality that normalized or improved after drug discontinuation
and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs," FDA officials said in a statement posted on the .
"Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options."
Professional labeling for finasteride has included statements about sexual adverse events since the drug's initial approval.
In 2011 the FDA required manufacturers to add erectile dysfunction to the list of potential sexual adverse events observed in some patients taking finasteride.
Nine physician groups listed a total of that they said are often medically unnecessary or cause more harm than good.
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